Guardant Health Receives FDA Approval for Guardant360 CDx Liquid Biopsy Test

Guardant Health has received FDA’s approval for its Guardant360 CDx blood test as a companion diagnostic for AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki).

The DNA sequencing assay identifies patients with unresectable or metastatic HER2-mutant nonsmall-cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations.

The assay, which detects gene alterations in tumor DNA circulating in the blood, provides comprehensive genomic profiling to assess patients’ eligibility for the therapy.

The FDA has also granted Enhertu an accelerated approval for treatment of this specific NSCLC patient population who have received a prior systemic therapy.